Director, Medical Affairs

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, hematology and infectious diseases.

Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking a Director, Medical Affairs will be instrumental in supporting the medical affairs function at Precigen for our first commercial launch. Reporting to the VP, Head of Medical Affairs, the Director, Medical Affairs will define the Medical Affairs strategy, advance collaborations with key opinion leaders and support the execution of plans for scientific engagement with health care practitioners, research groups, payers, and patient advocacy groups. Provide thought leadership and tactical execution for medical publication planning, medical education, medical information, field medical liaisons, and medical communication while working closely with the clinical development and regulatory teams.

The Director, Medical Affairs must have the ability to maintain scientific credibility while being commercially supportive, to communicate scientific results and effectively respond to medical inquiries from customers and key stakeholders.

DUTIES AND RESPONSIBILITIES:

• Leads the tactical implementation of the Medical Affairs strategic plan across Precigen's portfolio.
• Supports Medical affairs product lifecycle management and launch readiness plans
• Executes the delivery of timely, accurate and succinct communication of fair-balanced clinical and scientific presentations to healthcare professionals, both proactively and in response to requests for information, consistent with promotional compliance and regulatory requirements
• Leads Medical Affairs in the communication of scientific data to various audiences in the pre- and post-launch periods
• Creates current and future competitive advantages by understanding and addressing patient needs and demonstrating a deep understanding of competitors' strategies
• Represents PRECIGEN at medical meetings through Medical Affairs' Scientific Booth coverage and other related activities.
• Attend congresses as appropriate and develop meaningful internal reports of the congresses covered
• Represents Medical in the MLR process and ensures medical accuracy of all the materials submitted; submits medical materials as needed
• Creates and updates existing scientific materials (i.e. slide decks for field medical, medical narratives) ensuring fair balance and scientific accuracy
• Executes on Medical Affairs strategic imperatives and tactical plans to enhance healthcare practitioner education and improve patient outcomes.
• Develops, refines and implements all required Medical Affairs policies and procedures and SOPs.
• Provides Medical expertise to the Commercial organization as needed to assist in the development and execution of compliant commercial activities.
• Works closely with commercial and clinical development in writing target product profiles, forecasting life cycle management opportunities.
• Contributes to scientific affairs by authorizing and/or reviewing abstracts, presentations and manuscripts for medical accuracy and content.
• Partners with marketing, market access and commercial operations in developing launch plans
• Domestic Travel of 20-25%

EDUCATION AND EXPERIENCE :

• Scientific Degree, MD preferred
• 5+ years of Medical Affairs experience in a pharmaceutical/biotech setting.
• A hands-on approach to performing duties with a strong self-directed work ethic and attention to detail.
• Product launch experience in oncology, having successfully launched key products/brands preferred
• Broad working knowledge of industry compliance, clinical trial design publication strategy, and medical information process.
• Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment.
• Effective presentation skills to key stakeholders and key decision makers.
• Ability to work collaboratively across the organization to achieve corporate objectives.
• Ability to set and follow through goals with a sense of urgency while keeping broader strategic objectives in focus.
• Thorough understanding of the U.S. medical affairs dynamics

DESIRED KEY COMPETENCIES:

• Extensive understanding of and experience in both the clinical aspects and business of oncology, ideally cell & gene therapy specifically
• confident, positive attitude, enthusiastic and charismatic.
• Value based collaborator - respectful, accountable and collaborative.
• Self-motivated and independently minded.
• Positive interpersonal skills with the ability to interact with individuals from a variety of levels and functions.
• Understanding of the complex Regulatory, Development and Medical Affairs requirements in oncology
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Impactful written and verbal scientific communication.
• Successful and superior influencing skills across all levels of the organization and external collaborators.
• Problem solving and risk-mitigation skills.
• Appreciation of diversity and multiculturalism.
• Strategic and creative thinker.
• Ability to build working relations throughout the organization and with business partners to achieve business goals.
• Strong time management and organizational skills.
• Ability to manage multiple projects in a fast-paced environment.
• Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.

EOE MFDV